The primary purpose of this study is to test a new experimental recombinant Poliomyelitis vaccine (rPV) in comparison to the commercially available inactivated poliovirus vaccine. The design of the study is double-blinded, randomised and active controlled. The active controlled product is considered the commercially available vaccine (IPOL).
This study is a double-blinded, randomised, active controlled, Phase 1 clinical study, to determine the safety, tolerability, and reactogenicity of Serum Institute of India Pvt Ltd (SIIPL) rPV vaccine in comparison to the commercially available inactivated poliovirus vaccine (IPOL®, Sanofi) in up to 36 healthy adults aged between 18 and 60 years. This study will be conducted at a single study site in Australia. Participants will be randomised in a 2:1 ratio, to receive either investigational vaccine (rPV) or comparator vaccine (IPOL), respectively. The study vaccine will be administered as a single intramuscular (IM) injection into the deltoid muscle of the non-dominant upper arm. The participants will be followed for 30 days post vaccination.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
36
Recombinant Poliomyelitis Vaccine (VLP) is manufactured by Serum Institute of India Pvt. Ltd.
IPOL (inactivated poliovirus vaccine) is a marketed Sanofi
Doherty Clinical Trials Limited
East Melbourne, Victoria, Australia
The incidence, severity and relationship of solicited adverse events (AEs) during 7-day and unsolicited AEs during 30-day follow-up period after rPV and IPOL vaccination
Time frame: 30 days
Percentage of participants achieving seroprotection/seroconversion for poliovirus Types 1, 2 and 3, on Day 30.
Time frame: 30 days
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